Effects of Aromatase Inhibition Versus Testosterone in Older Men With Low Testosterone: Randomized-Controlled Trial.
| Status: | Completed |
|---|---|
| Conditions: | Cognitive Studies, Cognitive Studies, Depression, Healthy Studies, Osteoporosis, Orthopedic, Endocrine |
| Therapuetic Areas: | Endocrinology, Psychiatry / Psychology, Rheumatology, Orthopedics / Podiatry, Other |
| Healthy: | No |
| Age Range: | 65 - Any |
| Updated: | 11/8/2018 |
| Start Date: | March 2004 |
| End Date: | January 2015 |
The Effects of Aromatase Inhibition and Testosterone Replacement in Sex Steroids, Pituitary Hormones, Markers of Bone Turnover, Muscle Strength, and Cognition in Older Men
Background: Men≥65 years often produce lower levels of testosterone, meaning there is less
testosterone circulating to the tissues of the body. This is associated with negative effects
on muscle strength, bone density, sexual function, mood, and the ability to think to the best
of one's ability. Testosterone replacement therapy often involves injections, patches, or
gels that help to raise circulating testosterone levels, but these therapies often have side
effects because they lead to imbalance of other hormones. Researchers have been studying the
effectiveness of anastrozole, a drug that can lower estrogen levels while simultaneously
increasing testosterone levels, as a treatment for the negative effects of decreased
circulating testosterone levels that occur naturally with aging. Objectives: To evaluate
whether anastrozole is as effective as testosterone gel in improving bone and muscle
strength, hormone levels, and brain function in men over 65 years of age. Eligibility:
Healthy men at least 65 years of age who have low levels of testosterone. Design: The study
involves six study visits over a total of 12 months: screening, baseline, 6 weeks, 3 months,
6 months, and 12 months. All participants will receive calcium and vitamin D supplements to
take daily, and will be randomized to one of three groups:Testosterone gel and placebo
tablet, Anastrozole tablet and placebo gel, Placebo tablet and gel. Participants will have
the following tests at each specified visit:Screening: Blood tests and rectal ultrasound to
evaluate the prostate;Baseline: Blood and urine tests; growth hormone levels, muscle
strength, bone density, and balance evaluation; imaging studies; cognitive testing; and
questionnaires on quality of life, sexual function, depression, and urinary symptoms;Six
weeks: Blood tests and dose adjustment of the gel or tablet;Three months: Blood and urine
tests; growth hormone, muscle strength, bone density, and balance evaluation; and
questionnaires on quality of life, sexual function, depression, and urinary symptoms;Six
months: Blood and urine tests; muscle strength, bone density, and balance evaluation;
cognitive testing; and questionnaires on quality of life, sexual function, depression, and
urinary symptoms;Twelve months: Blood and urine tests; rectal ultrasound; muscle strength,
bone density, and balance evaluation; imaging studies; cognitive testing; and questionnaires
on quality of life, sexual function, depression, and urinary symptoms.
testosterone circulating to the tissues of the body. This is associated with negative effects
on muscle strength, bone density, sexual function, mood, and the ability to think to the best
of one's ability. Testosterone replacement therapy often involves injections, patches, or
gels that help to raise circulating testosterone levels, but these therapies often have side
effects because they lead to imbalance of other hormones. Researchers have been studying the
effectiveness of anastrozole, a drug that can lower estrogen levels while simultaneously
increasing testosterone levels, as a treatment for the negative effects of decreased
circulating testosterone levels that occur naturally with aging. Objectives: To evaluate
whether anastrozole is as effective as testosterone gel in improving bone and muscle
strength, hormone levels, and brain function in men over 65 years of age. Eligibility:
Healthy men at least 65 years of age who have low levels of testosterone. Design: The study
involves six study visits over a total of 12 months: screening, baseline, 6 weeks, 3 months,
6 months, and 12 months. All participants will receive calcium and vitamin D supplements to
take daily, and will be randomized to one of three groups:Testosterone gel and placebo
tablet, Anastrozole tablet and placebo gel, Placebo tablet and gel. Participants will have
the following tests at each specified visit:Screening: Blood tests and rectal ultrasound to
evaluate the prostate;Baseline: Blood and urine tests; growth hormone levels, muscle
strength, bone density, and balance evaluation; imaging studies; cognitive testing; and
questionnaires on quality of life, sexual function, depression, and urinary symptoms;Six
weeks: Blood tests and dose adjustment of the gel or tablet;Three months: Blood and urine
tests; growth hormone, muscle strength, bone density, and balance evaluation; and
questionnaires on quality of life, sexual function, depression, and urinary symptoms;Six
months: Blood and urine tests; muscle strength, bone density, and balance evaluation;
cognitive testing; and questionnaires on quality of life, sexual function, depression, and
urinary symptoms;Twelve months: Blood and urine tests; rectal ultrasound; muscle strength,
bone density, and balance evaluation; imaging studies; cognitive testing; and questionnaires
on quality of life, sexual function, depression, and urinary symptoms.
Approximately 20% of men over the age of 70 have low testosterone levels. In some studies,
testosterone replacement has resulted in improvement in bone mass, muscle strength, quality
of life and memory function. In the body, testosterone is converted into estrogen. Hence, it
is unclear whether these beneficial effects are due to testosterone or estrogen. Research has
shown that inhibition of estrogen production in men results in an increase in testosterone
levels.
In this study, patients will be assigned to one of three groups: one group will receive
testosterone gel and a placebo tablet, one group will receive a 1mg Anastrozole tablet and a
placebo gel, and one group will receive a placebo tablet and placebo gel. Each group will
receive a daily dose of calcium with vitamin D. The study requires 6 visits over a 12-month
period for testing and evaluation. Two of the 6 visits will require an overnight stay in the
hospital so that an intravenous (IV) line can be placed in the arm to allow samples to be
drawn throughout the night. Testing will include a cardiac stress test, a glucose tolerance
test, bone and muscle tests, evaluation of memory function, etc. For the safety of the
prostate, we will perform a prostate ultrasound at the start and end of the study and we will
monitor urinary symptoms, prostate specific antigen (PSA) levels and the prostate exam
throughout the study.
testosterone replacement has resulted in improvement in bone mass, muscle strength, quality
of life and memory function. In the body, testosterone is converted into estrogen. Hence, it
is unclear whether these beneficial effects are due to testosterone or estrogen. Research has
shown that inhibition of estrogen production in men results in an increase in testosterone
levels.
In this study, patients will be assigned to one of three groups: one group will receive
testosterone gel and a placebo tablet, one group will receive a 1mg Anastrozole tablet and a
placebo gel, and one group will receive a placebo tablet and placebo gel. Each group will
receive a daily dose of calcium with vitamin D. The study requires 6 visits over a 12-month
period for testing and evaluation. Two of the 6 visits will require an overnight stay in the
hospital so that an intravenous (IV) line can be placed in the arm to allow samples to be
drawn throughout the night. Testing will include a cardiac stress test, a glucose tolerance
test, bone and muscle tests, evaluation of memory function, etc. For the safety of the
prostate, we will perform a prostate ultrasound at the start and end of the study and we will
monitor urinary symptoms, prostate specific antigen (PSA) levels and the prostate exam
throughout the study.
- INCLUSION CRITERIA:
1. Men age 65 years or older
2. Serum testosterone level less than or equal to 350 ng/dl
3. Subject is able to complete an informed consent
EXCLUSION CRITERIA:
1. History of Stroke
2. History of Dementia
3. History of Diabetes
4. Blood pressure at rest of > 155/90 mmHg. Elevated systolic or diastolic reading
renders subject ineligible
5. Chronic medical condition, i.e. congestive heart failure
6. Arthritis, severe enough to prevent completion of the strength testing, history of
joint replacement of knees or hip.
7. Inability to walk 50 meters
8. Known disease of the bone and/or taking medications to treat osteoporosis, i.e.
Fosamax, Evista, Miacalcin
9. History of Gastric surgery
10. History of prostate cancer or any other cancers, including blood dyscrasias
11. History of severe benign prostatic hyperplasia (causing urinary problems)
12. History of heart attack or open-heart surgery within the past 6 months
13. Use of steroids within the past 3 months, including prednisone and/or cortisone
injections, and inhaled steroids. Topical steroid cream is acceptable.
14. If you do not agree to refrain from taking the drugs Viagra, Cialis or Levitra for the
duration of the study
15. Use of anabolic steroids, i.e. testosterone, (or any analog of testosterone)
Dehydroepiandrosterone or any growth promoters i.e. growth hormone itself or analogs
of growth hormone
16. Use of anti-androgen medications, i.e. Aldactone, Tagamet, Proscar, estrogens
17. Use of Dilantin or Phenobarbital
18. Alcohol intake > 30 grams (drink more than 2 beers per day OR more than 1 glass of
wine or cocktail daily)
19. Currently smokes any tobacco product
20. Having started a new medication during the past three months which may interfere with
the outcome measures of the study
21. Polycythemia
22. Prostate specific antigen > 4.0 ng/dl
23. Hematocrit < 36
24. Liver function tests greater than 2 times upper normal limits or abnormal
electrolytes, calcium or Parathyroid hormone , at the discretion of the investigator
25. Mini Mental Status Exam score less than or equal to 24
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